Zanubrutinib Plus GCVP (Obinutuzumab, Cyclophosphamide, Vindesine, Prednisolone) in Previously Untreated Follicular Lymphoma

Phase 2

Not yet recruiting

• Conditions: BTK Inhibitors; Follicular Lymphoma; Immunochemotherapy
• Interventions: Drug: ZGCVP

• Registration Number: NCT06918015
• Lead Sponsor: Zhejiang Cancer Hospital

Brief Summary

Previously untreated patients with follicular lymphoma are treated with the ZGCVP regimen (zanubrutinib, obinutuzumab, cyclophosphamide, vindesine, prednisolone) for 6 cycles.

Detailed Description

This is a prospective, single-arm, multi-center, phase II clinical study aiming at evaluating the efficacy and safety of zanubrutinib with GCVP (obinutuzumab, cyclophosphamide, vindesine, prednisolone) in untreated follicular lymphoma (FL). It includes screening (14 days before the first dose), treatment, and follow-up phases.

Screening: Recruitment subjects are grade 1-3a, stage III/IV or extensive stage II (unsuitable for radiotherapy) FL patients, with measurable lesions (short axis ≥1.5cm), meeting GELF criteria or having strong treatment desire.

Treatment: Patients receive the ZGCVP regimen for 6 cycles (21-day/cycle). Imaging evaluation was conducted at the end of every 2 cycles. Enhanced Computed Tomography (CT) and ultrasound are performed after 2 cycles of the ZGCVP regimen, while interim Positron Emission Tomography (iPET) is performed after 4/6 cycles. Bone marrow examination is required for those with initial bone marrow involvement after achieving Imaging complete response. Efficacy assessment indicators include complete response rate (CR), objection response rate (ORR), duration of response (DOR), progression free survival (PFS), overall survival (OS) and disease transformation rate according to Lugano 2014 criteria. Safety assessment indicators inlude adverse events basing on CTCAE 5.0.

Follow-up: Patients achieving CR at stage II underwent observation directly; those at stage III/IV receive obinutuzumab maintenance every 8 weeks for 2 years until disease progression or withdrawal. Patients with disease progression during treatment switch to second-line therapy.

Study Timeline

• Study First Submitted: 2025-03-20
• Status Verified: 2025-04
• Study First Submitted QC: 2025-04-05
• Study First Posted: 2025-04-09
• Last Update Submitted: 2025-04-12
• Last Update Posted: 2025-04-15
• Study Start: 2025-05-01
• Primary Completion: 2028-05-01
• Study Completion: 2030-05-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
zanubrutinib, obinutuzumab, cyclophosphamide, vindesine, prednisolone	ZGCVP	Patients receive the ZGCVP regimen (zanubrutinib, obinutuzumab, cyclophosphamide, vindesine, prednisolone) for 6 cycles at the following dose: 1. Zanubrutinib: 160mg orally twice daily; 2. Obinutuzumab: 1000mg intravenously on days 1, 8, and 15 of cycle 1 and on day 1 of subsequent 5 cycles; 3. Cyclophosphamide: 750m/m2 intravenously on days 1 of every cycle; 4. Vindesine: 3 mg/m2 (maximum dose 4 mg) intravenously on days 1 of every cycle; 5. Prednisolone: 30mg orally three times daily on day 1-5 of every cycle.

Primary Outcome Measures

Name	Time	Method
CRR	21days after the end of treatment	Complete response rate

Secondary Outcome Measures

Name	Time	Method
ORR	21days after the end of treatment	Objective response rate
DOR	the time from the date of initial assessment as complete response (CR) or partial response (PR) until the date of disease progression or death from any cause, whichever occurs first, assessed up to 24 months	Duration of response
PFS	the time from the date of initial treatment until the date of disease progression or death from any cause, whichever occurs first, assessed up to 24 months	Progression free survival
OS	the time from the date of initial treatment until the date of death from any cause, assessed up to 24 months	Overall survival
Disease Transformation Rate	From the first day of treatment until histological confirmation of transformation, death, or end of study follow-up, whichever occurs first, assessed up to 24 months	The probability of histologically confirmed transformation to aggressive lymphoma among enrolled follicular lymphoma patients

Trial Locations

Locations (1)

Zhejiang Cancer Hospital; 🇨🇳 Hangzhou, Zhejiang, China